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WHO Expert Committee on Biological Standardization.

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations to assure the quality safety and efficacy of vaccines blood products and other biological medicines and the establishment of international...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Organization, World Health
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Geneva : World Health Organization, 2007.
Colección:Technical Report Series.
Temas:
Acceso en línea:Texto completo

MARC

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505 0 |a Technical Report Series: WHO Expert Committee on Biological Standardization, 56th report; Contents; Introduction; General; International guidelines, recommendations and other matters related to the manufacture and quality control of biologicals; International reference materials; Antigens and related substances; Antisera; Blood products and related substances; Cytokines, growth factors and endocrinological substances; Diagnostic reagents; Annex 1: Guidelines for assuring the quality and nonclinicalsafety evaluation of DNA vaccines. 
505 8 |a Annex 2: Recommendations for inactivated rabies vaccinefor human use produced in cell substrates and embryonated eggsAnnex 3: Guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines (oral); Annex 4: Recommendations for the production, control and regulation of human plasma; Annex 5: WHO biosafety risk assessment and guidelines for the production and quality controlof human infl uenza pandemic vaccines; Annex 6: Recommendations for whole-cell pertussis vaccine; Annex 7: Biological substances -- international standards and reference reagents. 
520 |a This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations to assure the quality safety and efficacy of vaccines blood products and other biological medicines and the establishment of international biological reference standards for these products and related diagnostic devices. The report of particular relevance to manufacturers and national regulatory authorities starts with a discussion of general issues brought to the Committee's attention. The second part of the report contains written s. 
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